Affimed (AFMD) Highlights the Potential of its Innate Cell Engager AFM24 as EGFR-targeting Therapy for Solid Tumors as Monotherapy and in Combination with Adoptive NK Cell Transfer at AACR

• AFM24 induces strong tumor cell killing independent of KRAS mutations
• AFM24, in combination with adoptive NK cells, leads to dose-dependent tumor regression

Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announces pre-clinical data on its Innate Cell Engager (ICE®) AFM24 as monotherapy and in combination with adoptively transferred NK cells at the American Association for Cancer Research (AACR) Virtual Annual Meeting I.

AFM24, an EGFR/CD16A-binding ICE®, mediates antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) and has the potential to overcome toxicity and resistance hurdles associated with current EGFR signaling inhibitors through its differentiated mechanism of action. AFM24 induces NK cell-mediated ADCC against EGFR-expressing tumor cells even in the presence of competing IgG and can induce potent cell killing in tumors independent of KRAS mutations.

In addition, data from a xenograft mouse model demonstrate that AFM24 in combination with adoptively transferred NK cells results in dose-dependent tumor regression.

“AFM24’s novel mechanism of action is independent of EGFR signaling and has the potential to change the treatment paradigm for EGFR-expressing solid tumors,” said Dr. Arndt Schottelius, Affimed’s Chief Scientific Officer. “Demonstrating that AFM24, in combination with NK cells, shows tumor regression in vivo is an important pre-clinical proof of concept. Combination therapies with NK cells could broaden the potential AFM24 opportunities to treat a range of EGFR-expressing malignancies.”

Affimed is currently evaluating AFM24 as monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional information about the trial may be found at www.clinicaltrials.gov, using the identifier NCT04259450.

In March 2020, the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for a Phase 1/2a study investigating the combination of AFM24 with SNK-01, an autologous NK cell product of NKGen Biotech (formerly known as NKMax America), in cancer patients with EGFR-expressing tumors.

In February 2020, Affimed announced a clinical collaboration with Roche to explore the combination of AFM24 with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®).

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